UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027658
Receipt number R000031684
Scientific Title Effects of a group alcohol intervention for evacuees after the Great East Japan Earthquake
Date of disclosure of the study information 2017/06/06
Last modified on 2017/08/07 09:37:45

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Basic information

Public title

Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake

Acronym

Alcohol Intervention

Scientific Title

Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake

Scientific Title:Acronym

Alcohol Intervention

Region

Japan


Condition

Condition

The evacuees who might have risk of
alcohol abuse

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is to identify the risk factor of alcohol use disorders among evacuees
after the Great East Japan Earthquake,
and develop a group alcohol intervention
program.

Basic objectives2

Others

Basic objectives -Others

This presents two studies. The first
study aims to develop a questionnaire to
identify change in alcohol consumption
factors among the evacuees after the Great East Japan Earthquake. In the second study, we developed a group alcohol intervention program based on the Hizen Alcoholism Program by Yuzuriha (HAPPY) to investigate how the intervention could be effective for the evacuees who might have risk of
alcohol abuse

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

a. Participants' sociodemographic information and disaster-related situations
b. Burn-out Inventory
c. PHQ-9
d. AUDIT
e. Participants' drinking behavior
f. SOCRATES
g. Alcohol class evaluation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Alchol consumption between pre-post
alcohol class

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Only those that informed consent was
obtained

Key exclusion criteria

None

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maeda, Masaharu

Organization

Fukushima Medical University

Division name

Department of Disaster Psychiatry

Zip code


Address

Hikarigaoka 1 Fukushima-city, Fukushima

TEL

024-547-1887

Email

masagen@fmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ueda, Yuka

Organization

Fukushima Medical University

Division name

Department of Epidemiology

Zip code


Address

Hikarigaoka 1 Fukushima-city, Fukushima

TEL

024-547-1343

Homepage URL


Email

yukaueda@hotmail.com


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 30 Day

Last follow-up date

2016 Year 12 Month 21 Day

Date of closure to data entry

2017 Year 01 Month 10 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 06 Day

Last modified on

2017 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031684


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name